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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI CS INSERT TRL SZ4 9MM INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH TRI CS INSERT TRL SZ4 9MM INSTRUMENT Back to Search Results
Catalog Number 5531-T-409
Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Material Integrity Problem (2978)
Patient Problems Occlusion (1984); Injury (2348); Foreign Body In Patient (2687)
Event Date 02/16/2015
Event Type  Malfunction  
Event Description

During trialing of a triathlon total knee, the surgeon noticed pieces of plastic in knee joint. The surgeon trialed with a 9mm,11mm, and 13mm insert, after he removed each trial insert he had to pick pieces of plastic out of patients knee joint.

 
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Manufacturer Narrative

Conclusions: the reported event was confirmed. Chipping was observed on the distal rails of the triathlon cs insert trial. Scratches and indentations were observed on the articulating surface, underside, and distal rails. The observed damage likely occurred as a result of repeated use.

 
Event Description

During trialing of a triathlon total knee, the surgeon noticed pieces of plastic in knee joint. The surgeon trialed with a 9mm,11mm, and 13mm insert, after he removed each trial insert he had to pick pieces of plastic out of patients knee joint.

 
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Brand NameTRI CS INSERT TRL SZ4 9MM
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4592688
MDR Text Key19605358
Report Number0002249697-2015-00696
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5531-T-409
Device LOT Number53711
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/25/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/24/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/11/2015 Patient Sequence Number: 1
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